!!!!!!!! !!!!!!!!!!!!! Submitted!by:!!Nancy!Abbey! Executive!Director! MEDEC!!Reuse!of!SingleAUse!Devices!Task!Force!!!! June!4,!2014!
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1 BillC&17:ImprovingPatientSafetyby RegulatingReprocessedSingle&UseMedical Devices SubmissiontotheHouseofCommons StandingCommitteeonHealth Submittedby:NancyAbbey ExecutiveDirector MEDEC ReuseofSingleAUseDevicesTaskForce June4,2014
2 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and helpenablethesustainabilityofourpublicallyfundedhealthcaresystem. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities, and has sales of over $7 billion per annum. We are committed to supporting the growth of a strong and vibrant medical technology industrythatcontributestocanada sinnovationeconomy. June4,2014Page1of7
3 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth MEDECispleasedtopresentthisbrieftotheHouseofCommonsStandingCommittee on Health for consideration as part of its review for Bill CA17 An Act to amend the FoodandDrugsAct. MEDEC member companies are fully supportive of Bill CA17 to amend the Food and Drugs Act in order to improve patient safety by introducing measures that will strengthensafetyoversightandimprovereportingofseriousadverseevents. It is important to MEDEC members that patients and health care providers have confidenceinthesafetyofourhealthcaresystem.weallbenefitwhenpublictrustis atitshighest.thisisacrucialcomponenttotheabilityofinnovatorstobringbetter, new medical innovations into the system which ultimately enable better health outcomes and health care system sustainability. Something we all work together to strive for every day. Bill CA17 helps to build that public trust and grow Canadians confidenceinourhealthcaresystem. Wehaveanopportunitytoworktogethertofurtherstrengthenthislegislation.Afull listofmedecrecommendationsforbillca17isavailableinappendix1. WerecognizethatBillCA17 is intended to address a number of concerns specific to drugs,howeverthereisalongastandingmedicaldeviceissuethatwarrantsparticular attentionbythecommitteeforamendmentsandformsthebasisforthissubmission. ThisissueisregardingthereuseandreprocessingofsingleAusemedicaldevicesand thefactthatthereisnotanyfederalregulatoryoversightregardingthispracticeraises concernsforpatientsafetyandquestionsregardinglegalliability. June4,2014Page2of7
4 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth ReuseofSingle&UseMedicalDevices&ConcernforPatientSafety Inanefforttosavemoneyandreducemedicalwaste,hospitalsinCanadaarereusing medicaldevicesthatarelicensedbyhealthcanadatobeusedonlyonceoronasingle patientduringasingleprocedureandthenbediscarded. This practice is widespread. The Canadian Agency for Drugs and Technologies in Health (CADTH) reported in 2008 that 28% of hospitals in Canada and 42% of hospitalswithover250bedswerereprocessingsingleausedevices(suds)eitherina houseorbyathirdapartyreprocessor. i Among the devices being reused are electrophysiology catheters used to diagnose heartarrhythmias,harmonicscalpelsusedduringsurgerytocutandsealtissue,and burrsandbladesusedduringanorthopeadicprocedure. SingleAuse devices are not designed or licensed to be disassembled, cleaned, reassembled and reused, and doing so can jeopardize their performance, safety, and effectiveness. ii AdvisoryletterssentfromHealthCanadain2005and2007tohospitaladministrators andotherstakeholdersexpressedconcernthatthereuseofsingleausedevicesmaybe hazardoustopatients. FederalSituation NoRegulationsDespiteRepeatedCallsforAction It has been over ten years since the Auditor General of Canada recommended in March 2004 that Health Canada take action, such as regulating the reprocessing of singleausedevices,tomanagethehealthandsafetyrisksrelatedtothereuseofsinglea usemedicaldevices. iii June4,2014Page3of7
5 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth TherehavebeenrepeatedcallsfromtheHealthCanadaScientificAdvisoryPanelon Reprocessing of Medical Devices iv andthecanadian Orthopeadic Association v for HealthCanadatoregulatethereuseandreprocessingofsingleAusedevices. Health Canada has concluded that the Food and DrugsAct, from which the Medical Device Regulations derive their authority, is not intended to apply to the use of a deviceafteritssalethereforehealthcanadadoesn thavetheauthoritytoregulatethe reprocessing of singleause devices by hospitals or thirdaparty reprocessing companies vi AtthetimethatHealthCanadareviewedtheirregulatoryauthority,thevastmajority ofreprocessingwasbeingdonebyinahousehospitalstaff.thesituationhasevolved now with most hospitals outsourcing this activity and signing contracts with thirda partyreprocessingcompanies.therearenothirdapartyreprocessingcompaniesfor singleausedevicesbasedincanada. HealthCanadahaspubliclyacknowledgedthatbusinessmodelsforreprocessinghave changedovertime vii andthatatleastonereprocessorissellingreprocessedsingleause devicestocanadianhospitals. viii Health Canada has been unable to take action given the current Food and Drugs Act andmedicaldeviceregulations. HospitalsacrossthecountryareshippinguseddeviceslicensedforsingleAusetoU.S. based companies for reprocessing without any federal regulatory oversight for the devicesthatarethenbeingshippedbackforuseincanadianhospitals. PatientSafety WhyAmendmentsareImportant In Canada, original equipment manufacturers must present substantive scientific evidence of a device s safety, effectiveness and quality as required by the Food and June4,2014Page4of7
6 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth DrugsActand Medical Device Regulations, prior to being given authorization to sell andmarketadeviceincanada.therearealsospecificrequirementsfordocumenting andreportingadverseeventswithclearguidanceonhowtoissuearecallshouldthe situationwarrantsuchaction. Currently, thirdaparty reprocessing companies are not required to comply with Canada s Medical Device Regulations, raising important concerns regarding Health Canada sroleinensuringpatientsafety. 1. Device Licensing: Health Canada does not require thirdaparty reprocessing companiestosubmitsafety,effectivenessorqualitydataforthedevicestheyare sellingand/orshippingbackforuseincanadianhospitals. 2. Adverse Event Reporting: The Medical Device Regulations, specific to adverse eventreporting,currentlydonotapplytothirdapartyreprocessors.forinstance, thirdaparty reprocessing companies are not required to maintain records of reported problems related to a device nor are they required to report adverse eventstohealthcanada. 3. Device Recalls: Unlike original equipment manufacturers regulated by Health Canada, thirdaparty reprocessing companies are not required to provide a proposed strategy to the Health Minister as to how a device recall would be conductedandaproposedplantopreventarecurrenceoftheproblem. BillC&17Amendments&ToRegulateReprocessedSingle&UseDevices AmendmentstoBillCA17provideanopportunityforHealthCanadatobegrantedthe authoritytoregulatereprocessedsingleausedevices. June4,2014Page5of7
7 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth It is our recommendation that Health Canada regulate thirdaparty reprocessing companiesasmanufacturersinthecontextofcanada smedicaldeviceregulationsas hasbeenthecaseinothercountriesincludingtheunitedstates. ThedefinitionofamanufactureraccordingtoCanada smedicaldeviceregulationsis thefollowing: A person who sells a medical device under their own name, or under a trademark,design,tradenameorothernameormarkownedorcontrolledby the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or assigningitapurpose,whetherthosetasksareperformedbythatpersonoron theirbehalf. We are recommending amendments be made to Section 30 of the Act, as this is the section addressing regulationamaking authority for therapeutic products (including medicaldevices). Recommendation#1 Modify the regulationamaking power in section 30 (1.2)(a) to include reprocessingasalistedactivityinrespectofwhichauthorizationsmaybeissued, asfollows: Respectingtheissuanceofauthorizations=includinglicenses=thatauthorize,as the case may be, the import, sale, advertisement, manufacture, reprocessing, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment, suspension and revocation of such authorizations Recommendation#2 AddasubAsectiontosection30(1.2)providingfortheauthoritytomakeregulations requiring that reprocessors of devices licensed for singleause obtain therapeutic productauthorizationsinrespectofthosereprocesseddevices. June4,2014Page6of7
8 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth StrengtheningBillC&17 BenefitsfromAmendments ThebenefitofmakingtheseamendmentstoBillC=17tostrengthenpatientsafety wouldbe: Clarity regarding evidence clear, appropriate requirements for evidence to demonstratethatdeviceswillperformasintendedandaresafeforpatientswhen usedbyatrainedhealthcareprofessional. Greater transparency and traceability A to ensure that patients, doctors, industry and other stakeholders have access to clear information about the medicaldevicestheyuse. Enhanced vigilance and market surveillance to allow for a rapid identificationofadverseeventsandtoensurecoherentandtimelyaction. In conclusion,medecwants to reiterate itssupportforbillca17. We believe that these amendments can address a longastanding issue and enhance this important pieceoflegislationtoimprovepatientsafety. i HaileyD,JacobsP,RiesN,PolisenaJ,NormandinS,NooraniH,LaffertyS,GardamM.Reprocessingof single=usemedicaldevices:nationalsurveyofcanadianacute=carehospitals.(technologyreportnumber 104).Ottawa:CanadianAgencyforDrugsandTechnologiesinHealth(CADTH);2008 iimorrison,aanddowler,j.reprocessingofsingle=usemedicaldevices:a2011update(environmental Scanissue28).Ottawa:CanadianAgencyforDrugsandTechnologiesinHealth;2011. iiireportoftheauditorgeneralofcanada.chapter2:healthcanada=regulationofmedicaldevices March2004. ivhealthcanadasaparmdmeeting.panelrecommendations.feb2005 vcanadianorthopeadicassociation.reuseofsingle=usedevicespositionpaper.sept2011.available fromhttp:// vihealthcanada.lettertohospitaladministrators.updateonreprocessingandreuseofsingle=use MedicalDevices.October17,2007 viid.boyer,medicaldevicesbureau.futuredirectionofreprocessingsingle=usemedicaldevices.may viiip.neufeld,medicaldevicesbureau.regulatorystatusofreprocessingsingle=usedevices.nov2010 June4,2014Page7of7
9 Appendix(1( ( MEDEC(Recommendations(( Bill(C717( (An(Act(to(amend(the(Food(and(Drugs(Act( June(4,(2014( ( Suggested(amendments(to(regulate(reprocessed(single7use(devices( 1. Section 30 (1.2) (a) should be modified to include reprocessing as a listed activity in respectofwhichauthorizationsmaybeissued,asfollows: Respectingtheissuanceofauthorizations2includinglicenses2thatauthorize,asthecase may be, the import, sale, advertisement, manufacture, reprocessing, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment,suspensionandrevocationofsuchauthorizations 2. AddasubCsectiontosection30(1.2)providingfortheauthoritytomakeregulations requiring that reprocessors of devices licensed for singlecuse obtain therapeutic productauthorizationsinrespectofthosereprocesseddevices. ( Suggested(amendments(to(further(strength(Bill(C717( 3. BillC217lacksadefinitionfortheterm medicaldeviceincident usedforexamplein section5,21.8.wesuggesteitherusingtheterm prescribedmedicaldeviceincident, which would leave to a later regulation amendment which incidents are to be reported, or to add a definition that ensures that the Bill and its future regulations would follow the language or terminology currently used in the Canadian Guidance Document for Mandatory Problem Reporting for Medical Devices, January 14, 2011, whichisinternationallyalignedbasedonworkoftheghtf(nowimdrf). Other Health Canada documents (e.g. Medical Device Problem Reporting by Health CareFacilities,MedicalProfessionalsandotherdeviceusers)define incident broadly as anyconcernsthatrelatetothesafety,effectivenessorqualityofamedicaldevice that have been detected during use or identified during device examination and testing prior to use. The problems include deficiencies in the design of the device, defectsarisingfromthemanufacturingandinadequacyorerrorsinlabelingsuchas directionsforuse. The industry would need clarity regarding the applicable definition also under the aspect that section 5, 21.8 is about serious adverse drug reactions and a medical deviceincident,whichdoesnotsoundbalancedandcouldleadtotheimpressionthat theterm medicaldeviceincident isusedinthebroadersense.ifitwerethecase,this wouldnotfindagreementbytheindustry.
10 MEDEC Brief (Bill C-17): House of Commons Standing Committee on Health June 4, The powers of the Minister in section 3, 21.1, 21.2, 21.3(1), and 21.3 (2) should enable action that is evidence based and be in line with other relevant Canadian legislation.inordertoclarifythismedecrequeststhattheseclausesopenwith Ifthe Ministerbelievesonreasonablegrounds,languagewhichisconsistentwithcurrent CMDRsandalsousedintheCanadaConsumerProductsSafetyAct. 5. ThepowersoftheMinisterinsection3,21.2,21.3,21.31,and21.32(b)willlimitthe authority given to the licence holder in the licensing process during application review.medecrequeststhattheseclausesbeamendedby Priortoissuingsuchorder the Minister shall provide the holder of a therapeutic product authorization the opportunitytobeheard. In case the request relates to regulations related to these powers it should be considered in the drafting process in order to provide a balanced framework that containsareasonableapproachtowardsdisputeresolution. 6. Section3,21.3(1)(b)shouldbemodifiedto holdtheproductinquarantine,orsend theproductorcauseittobesent,toaplacespecifiedintheorder. The nature of certain medical devices may require to rather holding them in quarantineattheircurrentlocationasshipmentanddetentioncouldcompromisethe qualityandintegrityofthedevice. 7. Section3,21.3(3)shouldbemodifiedto ordersthem,oranotherperson,towithdraw fromthemarket. The definition of a recall in Canada for medical devices is very broad and includes a varietyofcorrectiveactions dependingontheincidence,situation,andtypeofdevice andastopsalewouldprobablynotbeappropriateforallthese recall situations.italso needstobeclearthata correctiveaction provideditmitigatestherisk removesthe reasonfortheordertostopselling. Appendix1:Page2of2
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